Enlite Sensor (MMT-7008)
FDA premarket approval P120010/S141 · decided 2022-04-29
Approval details
- PMA number
- P120010
- Supplement
- S141
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Enlite Sensor (MMT-7008)
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2022-04-01
- Decision date
- 2022-04-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Addition of an alternate bioburden and sterility contract testing laboratory for the Enlite sensor and the Guardian Sensor (3). The Enlite sensor is a components of the MiniMed 530G, 630G, Paradigm Real-Time Revel, and iPro2 CGM systems. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect, 670G and 770G systems.
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